TREATMENT

ZERONA
Visit Zerona
VELASHAPE
SLIM U CANADA
VASER SHAPE
LIPOSONIX
ZELTIQ
i-LIPO
i-LIPO/LIPO 2000.
LAPEX BCS
LAPEX BCS/LAPEX 2000.
VENUS CONCEPT
VENUS CONCEPT/VENUS FREEZE.
LIPOSUCTION
GASTRIC BYPASS
GASTRIC BYPASS/LAP BAND/SURGERY.
ULTRASHAPE

AVG COST

$130 - $310
$130 - $310 per full body treatment depending on number of treatments.
$300 - $600
$300 - $600 per session, 3-9 sessions required [22]
$200 - $400
$200 - $400 per treatment per area.
$2500 - $3000
$2500 - $3000.
$150 - $200
$150 - $200 per treatment with each patient requiring up to 15 treatments for a total of $3000 [13].
$1200 - $1700
$1200 - $1700 per 1 hr treated /area [28].
$200 per session
$200 per session, requires 4-8 [8].
$200 +
$200 + per session with 4 - 8 sessions recommended. [8].
$150 - 400
$150 - 400 per treatment (depending on area).
$2000 - $8000
$2000 - $8000 1 - 4 hours, surgical depending on area and surgeon.
$15000 - $40000
$15000 - $40000.
$1500 - $3200
$1500 - $3200 depending on size of area.

EXPECTED OUTCOMES

5 inches
Lose on average 5 inches in waist, hips, thigh and arm circumference reduction combined in 2 weeks.
1.25 cm
1.25 cm total loss across abdomen after three weeks, with 1.43 cm and 1.82 cm at 1 and 3 month follow-ups respectively. [21].
No published data
No published data.
Study on-going
No published data. Study on-going. Observational study only (non-randomized, non-controlled). [30].
4.6 cm (1.85 inches)
4.6 cm (1.85 inches) from the waist circumference in treated area [10].
22.4%
Average loss of 22.4% of small area treated at 4 months which equates to a reduction of 1.8 mm or 0.18 cm or 0.07in. [27] Furthermore, 32 subjects were enrolled but only 10 subjects underwent ultrasound evaluation [27].
No peer-reviewed
No peer-reviewed publications.** No results can be anticipated without at least peer reviewed data. [8]****.
No reliable results
No reliable results available. Only available study added NON study treatment group together with a control group which is medically unethical in determining results.****.
3.9 cm
Average loss of 3.9 cm after 8 weeks with measurement including 3 separate points.
5 to 8 lbs
Removal of a max 5 to 8 lbs of localized fat deposits (beyond 8 lbs incurs far too much risk to patient).
Extreme reduction
Extreme weight reduction.
2 - 4 cm
2 - 4 cm circumferential reduction in treated area.

POSSIBLE CANDIDATES

Almost everyone
Almost everyone.
10-15 pounds
Slender patient who has visible cellulite in a specific area and are within 10-15 pounds of ideal body weight.
10-15 pounds
Slender patient who is within 10-15 pounds of ideal body weight.
5-30 pounds
Non-overweight patients must be within 5-30 pounds of ideal body weight and in good medical health.
30 pounds
Non-overweight patients within 30 pounds of ideal body weight.
5-15lbs
Slender patients who are between 5-15lbs of their ideal body weight.
NO peer-reviewed
NO peer-reviewed publications.** No patient qualifications can be determined with any level or assurance of patient safety without at least peer-reviewed data. [8]****
NO peer-reviewed
NO peer-reviewed publications. No patient qualifications can be determined with any level or assurance of patient safety without at least peer-reviewed data. ****
5-15 lbs
Slender patients who are between 5-15 lbs of their ideal body weight.
5-30 pounds
Non-overweight patients must be within 5-30 pounds of their ideal body weight and in good medical health.
Overweight patients
Overweight patients who have a BMI of at least 40 or who have a BMI of at least 30 with 1 or more obesity related comorbid conditions.
20 pounds
Slender patients who are in good overall health, within 20 pounds of ideal body weight. May not be used near bone or when metal is present in body.

LENGTH OF PROCEDURE

40 minutes
40 minutes x 3 treatments a week for 3, 4 or 12 weeks, depending on patient's needs.
1 hour
1 hour, non-surgical, min 8-9 treatments, twice a week.
10 - 20 minutes
10 - 20 minutes
1 - 4 hours
1 - 4 hours
1 - 2 hours
1 - 2 hours
1 - 3 hours
1 - 3 hours per area, non-surgical.
40 - 50 min
40 - 50 min, paddles being relocated every 10 mins [8]
30 - 40 min
30 - 40 min, paddles being relocated every 10 mins. [8]
20 - 60 minutes
20 - 60 minutes with 1 session per week for 6 to 10 weeks
1 - 4 hours
1 - 4 hours, surgical
2 - 3 hours
2 - 3 hours, surgical
1 - 3 hours
1 - 3 hours per area, non-surgical

TREATMENT

ZERONA
Visit Zerona
VELASHAPE
SLIM U CANADA
VASER SHAPE
LIPOSONIX
ZELTIQ
i-LIPO
i-LIPO/LIPO 2000.
LAPEX BCS
LAPEX BCS/LAPEX 2000.
VENUS CONCEPT
VENUS CONCEPT/VENUS FREEZE.
LIPOSUCTION
GASTRIC BYPASS
GASTRIC BYPASS/LAP BAND/SURGERY.
ULTRASHAPE

SIDE EFFECTS AND DEATH

ZERO side effects
ZERO negative side effects. In over 60,000 patients and millions of individual treatments ZERO negative events have been reported.
Erythema, edema
Erythema, edema
NO peer-reviewed
NO peer-reviewed publications. Uses Zerona's Histological Evidence as own. *** [8] Side effects are unknown. No pain.
Burns, bleeding...
Burns, bleeding, seepage, infection, bruising, swelling, tenderness, subdermal coagulative nercrosis (tissue death). Fat cell death. [10].
Burns, bruising...
Burns, bruising, tenderness, pain, discomfort, subdermal coagulative nercrosis (tissue death). Fat cell death. [9-12].
Bruising, tingling...
Bruising, tingling, tenderness, asymmetry, cramping, numbness, permanent nerve damage, tissue necrosis (death), sometimes uncontrollable blistering, blood in stool. Fat cell death. [29]
NO peer-reviewed
NO peer-reviewed publications.** Uses Zerona's Histological Evidence as own. *** [8] Side effects are unknown. No pain. [8]****
NO peer-reviewed
NO peer-reviewed publications. Uses Zerona's Histological Evidence as own. *** [8] Side effects are unknown. No pain.
Erythema, edema...
Erythema, edema, pain. [6]
FDA website reports
FDA website reports 16-20 deaths per 100,000 procedures (physician selection is critical). Bruising, swelling, pain, tenderness, numbness, asymmetry, dimpling, scarring, tissue death. Fat cell death.
Bypass deaths
Gastric Bypass deaths: 1-5 in 500. Lap banding deaths: 1 in 10,000. Complications: ulceration, infection, gastritis, slippage, erosion of -band into stomach space, severe pain. 50% opt to remove band within 10 years, 4 out of 5 clients will experience complications. Fat cell death.
Bruising, redness...
Bruising, redness, swelling, tenderness, blistering, scarring, risk of femoral artery dissection. Fat cell death.

RECOVERY

NONE
NONE.
1 week
1 week between each session
Unknown
Unknown.
2 - 4 weeks
2 - 4 weeks.
Several hours...
Several hours-several weeks.
Hours to months
A few hours to a several months.
Unknown
Unknown.
Unknown
Unknown.
Unknown
Unknown.
2 - 4 weeks
2 - 4 weeks.
3 - 6 weeks
3 - 6 weeks if no complications.
Hours to weeks
Several hours-several weeks.

RESULTS IN HOW LONG

1 - 4 days
1 - 4 days.
3 - 4 weeks
3 - 4 weeks, on going maintenance.
2 - 4 weeks
2 - 4 weeks.
3 - 4 months
3 - 4 months.
8 - 12 weeks
8 - 12 weeks.
2 - 4 months
2 - 4 months.
Unknown
Unknown.
Unknown
Unknown.
Unknown
Unknown.
3 - 6 months
3 - 6 months.
Varies
Varies.
1 - 4 months
1 - 4 months.

FDA AND HEALTH CANADA

FDA LEVEL ONE
FDA LEVEL ONE (highest level), double blind, placebo controlled, randomized, multi-site clinical trial. Cleared for the safe and effective reduction of an average of 5 inches in waist, hips, thigh and arm circumference reduction combined in 2 weeks.
NO evidence-based
NO evidence-based medicine. FDA cleared for the temporary relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite and the temporary reduction of thigh circumference only (K071872). Active Health Canada license for massager to relieve pain and temporary reduction in the appearance of cellulite. [21]
FDA Equivalency
FDA Equivalency Approval for therapeutic heating.
NO published data
NO published data. FDA Equivalency Approval based on 1976 massager for relief of minor muscle aches and pain, relief of muscle spasms, and temporary reduction of cellulite. [20].
NO evidence-based
NO evidence-based medicine. FDA cleared for non-invasive waist circumference reduction (K100874). Active Health Canada license for body sculpting.
NO evidence-based
NO evidence-based medicine. NO placebo-controlled studies. FDA cleared for reduction of discrete fat bulges in lateral areas ONLY with a guidance document that must be presented to everyone outlining the risks associated with this device. Active Health Canada license for fat layer reduction through cold assisted lipolysis. [24] [25] [26].
NO evidence-based
NO evidence-based medicine. FDA cleared for the temporary relief of minor muscle aches and pains under a 1976 totical heating device Equivalency Approval (K101366). No Health Canada license.
NO evidence-based
NO evidence-based medicine. FDA cleared for the temporary relief of minor muscle aches and pains under a 1976 totical heating device Equivalency Approval (K081962). Active Health Canada license for body contouring and temporary reduction in the appearance of cellulite.
No evidence-based
No evidence-based medical information. FDA Equivalency Approval for treatment of wrinkles and rhytides (K100586)..
Cannulas cleared
FDA approvals for the cannulas used to perform the procedures.
FDA cleared for
FDA cleared for use on clients who have a BMI of at least 40kg per m2 or who have a BMI of at least 30kg per m2 with 1 or more obesity related comorbid conditions.
NO evidence-based
NO evidence-based medicine. NOT FDA cleared in any category. *****

*Evidence-Based Medicine = completion of a level 1 prospective, placebo-controlled, randomized (1:1), double-blinded, multi-centered clinical study
** No peer-reviewed publications signifies that a general search at http://www.ahsl.arizona.edu.ezproxy1.library.arizona.edu/ebmsearch/CollegeofMedicine/ using the device name and/or company name did not prod
*** Prior to the development of the Zerona device, Zerona-like device produced by the same manufacturer of Zerona (Erchonia Medical) assessed laser's effect on fat tissue. The parameter of laser that has been shown to modulate the fat cell is 635nm between 5 and 20mW. Competitors using the wrong output parameters continuously cite Dr. Neira' s work using the Zerona parameters.
**** Caruso-Davis M, et al. The efficacy of the Lapex2000 lipolaser in body contouring and fat reduction. Obesity. 2007;15:A99. Although it says Obesity Journal, a search on the Obesity Journal website cannot loc
[1] Friedman et al. The use of hybrid radiofrequency device for the treatment of rhytides and lax skin. Dermatol Surg. 2007;33(5):543-51.
[2] de Pino E, et al. Effect of controlled volumetric tissue heating with radiofrequency on cellulite and the subcutaneous tissue of the buttock and thighs
[3] Braun M. Combination of a new radiofrequency device and blue light for the treatment of acne vulgaris. J Drugs Dermatol. 2007;6(8):838-40
[4] http://www.body-contouring.com/accentxl.aspx
[5] Atiyeh BS, Dibo SA. Nonsurgical nonablative treatment of aging skin: radiofrequency technologies between aggressive marketing and evidence-based efficacy. Aesthetic Plast Surg. 2009;33(3):283-94
[6] Elsaie ML, et al. Nonablative radiofrequency for skin rejuvenation. Dermatol Surg. 2010;36(5)577-89.
[7] http://exilisday.com/faqs/
[8] http://www.synergyfatloss.com/311%20paient%20study.pdf
[9] Fatemi A. High-intensity focused ultrasound effectively reduces adipose tissue. Semin Cutan Med Surg. 2009;28(4):257-62.
[10] http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100874.pdf
[11] Gadsden E, et al. Evaluation of a novel high-intensity focused ultrasound device for ablating subcutaneous adipose tissue for noninvasive body contouring: safety studies in human volunteers. Aesthet Surg J. 2011;31
[12] Jewell ML, et al. Evaluation of a novel high-intensity focused ultrasound device: preclinical studies in a porcine model. Aesthet Surg J. 2011;31(4):429-34.
[13] http://www.nonsurgicalliposuctionguide.com/nonsurgicalliposuctionliposonix.html
[14] Kulick MI. Evaluation of a non-invasive, dual-wavelength laser-suction and massage device for the regional treatment of cellulite. Plast Reconstr Surg. 2010;125(6):1788-96.
[15] Lach E. Reduction of subcutaneous fat and improvement in cellulite appearance by dual-wavelength, low-level laser energy combined with vacuum massage. J Cosmet Laser Ther. 2008;10(4):202-9.
[16] http://www.anti-aging.org/content/smoothshapes.asp
[17] Anolik R, et al. Radiofrequency devices for body shaping: a review and study of 12 patients. Semin Cutan Med Surg. 2009;28(4):236-43.
[18] http://www.plasticsurgeryportal.com/thermage/2004010614155239736615
[19] http://www.510kdecisions.com/applications/index.cfm/fuseaction/list/applicant/THERMAGE,%20INC./index.cfm
[20] http://www.prnewswire.com/news-releases/sound-surgical-technologies-introduces-vaser-shape-mc1-102857024.html
[21] Brightman L, et al. Improvement in arm and post-partun abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device. Lasers Surg M
[22] http://www.body-contouring.com/velasmooth.aspx
[23] http://www.realself.com/review/fort-worth-tx-cellulite-treatment-venus-freeze-skin-tightening-cellulite
[24] Nelson AA, et al. Cryolipolysis for reduction of excess adipose tissue. Semin Cutan Med Surg. 2009;28(4):244-9
[25] Klein KB, et al. Non-invasive Cryolipolysis for subcutaneous fat reduction does not affect serum lipid levels or liver function tests. Lasers Surg Med. 2009;41(10):785-90.
[26] Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009:41(10):703-8.
[27] Dover J, et al. A prospective clinical study of non-invasive Cryolipolysis for subcutaneous fat layer reduction-Interim Report of Available Subject Data. Laser Surg Med. 2009;S21:45.
[28] http://www.realself.com/question/zeltiq-cost
[29] Coleman SR, et al. Clinical efficacy of noninvasive Cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009;33(4):482-8.
[30] Neira R, et al. Effects of the electric laser diode beam on in vitro human adipose tissue culture. Congreso Bolivariano de Cirugia Plastica Reconstructive. 2001
[31] Neira R, et al. Fat liquefaction: Effect of low level laser energy on adipose tissue. Plast Reconstr Surg. 2002;110:912-922
[32] Neira R, et al. In vitro culture of adipose cells after irradiating them with a low level laser device. Congresso Bolivariano de Cirugia Plastica Reconstructiva. 2001
[33] Neira R, et al. Fat liquefication: effect from low level laser energy. Presented at the Society of Latin American Plastic Surgeons Meeting; Orlando, Fl.; Nov.5, 2001
[34] Ramirez-Montanan A, et al. Changes on human fat cell's architecture after low-level laser exposure. Paper presented at: 34th National Congress of Mexican Plastic and Aesthetic and Reconstructive Surgery Associat
[35] Neira R, Jackson R, et al. Low-level laser assisted lipoplasty: Appearance of fat demonstrated by MRI on abdominal tissue. Am J Cosmet Surg. 2001;18(3):133-40.
[36] Maloney R. Body Contouring with a multiple diode laser system. Lasers Surg Med. 2008;S21:179.
[37] Jackson R, et al. Low level laser therapy as a non-invasive approach for body contouring: A randomized, controlled study. Lasers Surg Med. 2009;31:799-809

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